ACCUFILL BSM 5CC
Received Oct 30, 2020 · Event occurred Nov 11, 2019
Report 0001225112-2020-00004 · MDR key 10762153
Device
Generic name
Biologics, Bone Substitute
Manufacturer
Etex CorporationModel number
NICatalog number
201.050
Lot number
102065
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
53 YR
- Arthritis
- Pain
- Fibrosis
- Arthritis
- Pain
- Fibrosis
Narrative
Additional Manufacturer Narrative
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPON RECEIVING ADDITIONAL INFORMATION OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT SHOULD BE VOIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
Description of Event or Problem
ADDITIONAL INFORMATION RECEIVED NOTES THAT THE PATIENT STATED THE PAIN STARTED AFTER SHE RETURNED TO WORK, STOPPED TAKING NAPROXEN, AND RESUMED TEACHING AEROBICS. PATIENT STATES THAT SINCE SHE HAS DECREASED HER ACTIVITY AND RESUMED TAKING IBUPROFEN AND NAPROXEN, THE PAIN HAS BEEN SCALING DOWN.
Additional Manufacturer Narrative
(B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM# 402.202; LOT# KC04875. ITEM# 308.041; LOT# 34857. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT WAS DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
Description of Event or Problem
IT WAS REPORTED PATIENT PARTICIPATED IN A CLINICAL STUDY SUBCHONDROPLASTY HIP OUTCOMES STUDY, AND UNDERWENT THE PROCEDURE ON THE LEFT HIP APPROXIMATELY ONE (1) YEAR AND NINE (9) MONTHS AGO. THE SITE REPORTED THE PATIENT EXPERIENCING PAIN IN THE LEFT HIP AND THE SURGEON REPORTED THE ADVERSE EVENT AS POSSIBLY RELATED TO THE PROCEDURE AND IMPLANT. PATIENT UNDERWENT A MEDICAL INTERVENTION/MODIFICATION AND WAS TO RESUME NAPROXEN AND IBUPROFEN. APPROXIMATELY SEVEN (7) MONTHS AGO, PATIENT WAS REVISED TO A THA. ACCORDING TO THE SURGEON, THE RELATIONSHIP IS CONSIDERED POSSIBLY RELATED TO THE PROCEDURE AND STUDY IMPLANT, BECAUSE IT IS IMPOSSIBLE TO DETERMINE IF THE NEED FOR A THA RESULTED FROM THE STATE OF HER HIP OR THE SURGERY/IMPLANT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.